Breast NeoplasmOncoHypnoseNCT03330717
Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery
A study testing General anesthesia, Hypnosis sedation and General anesthesia with preoperative session of hypnosis in people with Breast Neoplasm, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial summary
The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- General anesthesia, Hypnosis sedation and General anesthesia with preoperative session of hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Nov 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Signed informed consent form
- Patient has to be in possession of her administrative laws and affiliated to the social security insurance.
- The patient must have a diagnosis of resectable breast cancer (in situ or invasive breast cancer). . Surgical procedure must include evaluation of the axillary area (sentinel lymph node biopsy and or axillary dissection)
Who cannot join
- Patient under 18 years old
- No signed informed consent form
- Patients who haven't her social security insurance and prisoners are not eligible.
- No evaluation of the axillary area.
- Breast cancer in men
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, 7100
About this study
Official title: Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation (Virtual Reality) in the Breast Oncologic Surgery
The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery.
Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up.
Comparisons are also performed in substudies defined by treatments modalités. Inflammatory parameters s ( CRP_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.
Read the detailed description
Hypnosis has already demonstrated benefits among breast cancer patients undergoing oncologic surgery. Different side effects were measured during the post operative period and at each follow up visit by physicians in order to carefully compare side effects in the 3 armes of patients..
Our hypothesis was that hypnosis sedation generates less perioperative inflammatory reaction.
A substudy of 50 patients was also dedicated to the investigation ofsalivary immunoglobulins and dosage of differents endocannabinoids
- Conditions
- Breast Neoplasm
- Being tested
- General anesthesia, Hypnosis sedation, General anesthesia with preoperative session of hypnosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Patients will undergo oncologic breast surgery on general anesthesia.
Hypnosis sedationProcedure or surgery
Patients will undergo oncologic breast surgery on hypnosis sedation.
General anesthesia with preoperative session of hypnosisProcedure or surgery
Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Placebo comparator | Patients will undergo oncologic breast surgery on general anesthesia. Receives: Procedure: General anesthesia |
| Hypnosis sedation | Experimental | Patients will undergo oncologic breast surgery on hypnosis sedation. Receives: Procedure: Hypnosis sedation |
| General anesthesia with preoperative session of hypnosis | Experimental | Patients interested in hypnosis but too anxious to have surgery while on hypnosis sedation will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation using technology of virtual reality Receives: Procedure: General anesthesia with preoperative session of hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the days spent at the hospital post-surgery between the three groups
The aim of the study is to compare the recovering period hospitalisation and the different side effects (pain, anxiety, fatigue and consumption of pain killers ) during the post opérative period ( day 0, 1, 8- and at each follow up visit) between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery
Measured: Day 0, 1, 8 and every 3 months for 2 years after surgery
Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio)
Blood test performed
Measured: Day 0, 1, 8
Secondary outcomes (1)
Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation
Blood and salivary simples to observe if hypnosis modifies salivary parameters and endocannabinoids system
Measured: Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Nov 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine Berlière, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330717
- Sponsor's protocol ID
- 2016/08JUL/311
- Acronym
- OncoHypnose
- Status last verified
- Jun 2021
- First submitted
- 19 Oct 2017
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation (Virtual Reality) in the Breast Oncologic Surgery
- ClinicalTrials.gov ID
- NCT03330717
- Acronym / sponsor ID
- OncoHypnose / 2016/08JUL/311
- Conditions
- Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery.
Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up.
Comparisons are also performed in substudies defined by treatments modalités. Inflammatory parameters s ( CRP_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.
Detailed description
Hypnosis has already demonstrated benefits among breast cancer patients undergoing oncologic surgery. Different side effects were measured during the post operative period and at each follow up visit by physicians in order to carefully compare side effects in the 3 armes of patients..
Our hypothesis was that hypnosis sedation generates less perioperative inflammatory reaction.
A substudy of 50 patients was also dedicated to the investigation ofsalivary immunoglobulins and dosage of differents endocannabinoids
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Placebo comparator | Procedure: General anesthesiaPatients will undergo oncologic breast surgery on general anesthesia. |
| Hypnosis sedation | Experimental | Procedure: Hypnosis sedationPatients will undergo oncologic breast surgery on hypnosis sedation. |
| General anesthesia with preoperative session of hypnosis | Experimental | Procedure: General anesthesia with preoperative session of hypnosisPatients interested in hypnosis but too anxious to have surgery while on hypnosis sedation will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation using technology of virtual reality |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Signed informed consent form
- Patient has to be in possession of her administrative laws and affiliated to the social security insurance.
- The patient must have a diagnosis of resectable breast cancer (in situ or invasive breast cancer). . Surgical procedure must include evaluation of the axillary area (sentinel lymph node biopsy and or axillary dissection)
Key exclusion criteria (5 listed)
- Patient under 18 years old
- No signed informed consent form
- Patients who haven't her social security insurance and prisoners are not eligible.
- No evaluation of the axillary area.
- Breast cancer in men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaPatients will undergo oncologic breast surgery on general anesthesia. | Procedure or surgery | General anesthesia |
| Hypnosis sedationPatients will undergo oncologic breast surgery on hypnosis sedation. | Procedure or surgery | Hypnosis sedation |
| General anesthesia with preoperative session of hypnosisPatients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation. | Procedure or surgery | General anesthesia with preoperative session of hypnosis |
Primary outcome
Number of the days spent at the hospital post-surgery between the three groups
Time frame: Day 0, 1, 8 and every 3 months for 2 years after surgery
The aim of the study is to compare the recovering period hospitalisation and the different side effects (pain, anxiety, fatigue and consumption of pain killers ) during the post opérative period ( day 0, 1, 8- and at each follow up visit) between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery
Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio)
Time frame: Day 0, 1, 8
Blood test performed
1 secondary outcome
Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation
Time frame: Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Berlière, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia, Hypnosis sedation and General anesthesia with preoperative session of hypnosis in people with Breast Neoplasm, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of the days spent at the hospital post-surgery between the three groups (time frame: Day 0, 1, 8 and every 3 months for 2 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.